Diskets Dispersible (Oral)

Deaths due to too-rapid titration, drug interactions, or cardiac and respiratory side effects have occurred with methadone use for opioid dependence. Respiratory depression is the main hazard associated with methadone administration. QT interval prolongation and serious arrhythmias (torsades de pointes) have been observed during treatment with methadone. Only approved hospitals and pharmacies can dispense oral methadone for the treatment of narcotic addiction .

Oral route(Tablet;Solution)

Warning: Addiction, Abuse And Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Life-Threatening QT Prolongation; Neonatal Opioid Withdrawal Syndrome; Interactions With Drugs Affecting Cytochrome P450 Isoenzymes; Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants; And Treatment For Opioid AddictionAddiction, Abuse, and Misuse: Methadone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing methadone hydrochloride tablets, and monitor all patients regularly for the development of these behaviors and conditions .Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect, especially during the initial dosing period or following a dose increase. Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase. Proper dosing and titration are essential and methadone hydrochloride should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for toxification and maintenance treatment of opioid addiction .Accidental Ingestion: Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone .Life-Threatening QT Prolongation: QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients with risk factors for development of prolonged QT interval, a history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of methadone hydrochloride tablets during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. The balance between the risks of NOWS and the benefits of maternal methadone hydrochloride use may differ based on the risks associated with the mother’s underlying condition, pain, or addiction. Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur .Cytochrome P450 InteractionThe concomitant use of methadone hydrochloride tablets with all cytochrome P450 3A4, 2B6, 2C19, 2C9 or 2D6 inhibitors may result in an increase in methadone plasma concentrations, which could cause potentially fatal respiratory depression. In addition, discontinuation of concomitantly used cytochrome P450 3A4, 2B6, 2C19, or 2C9 inducers may also result in an increase in methadone plasma concentration. Follow patients closely for respiratory depression and sedation, and consider dosage reduction with any changes of concomitant medications that can result in an increase in methadone levels .Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of methadone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate .Limit dosages and durations to the minimum required .Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting the daily methadone dose .Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction:For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration .

Commonly used brand name(s)

In the U.S.

Diskets Dispersible

Dolophine

Methadone HCl Intensol

Methadose

Available Dosage Forms:

Tablet for Suspension

Tablet

Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Diskets Dispersible

Methadone is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long period of time. This medicine should not be used to treat pain that you only have once in a while or "as needed". Methadone is also used together with medical supervision and counseling to treat opioid addiction (eg, heroin or other morphine-like drugs).

Methadone is an opioid (narcotic) analgesic (pain medicine). It acts on the nervous system to relieve pain.

This medicine is available only with your doctor's prescription.

Before Using Diskets Dispersible

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of methadone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methadone in the elderly. However, elderly patients are more likely to have age-related heart, kidney, liver, or lung problems, which may require caution and an adjustment in the dose for patients receiving methadone.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Amisulpride

Bepridil

Cisapride

Dronedarone

Fluconazole

Itraconazole

Ketoconazole

Mesoridazine

Nalmefene

Naltrexone

Nelfinavir

Pimozide

Piperaquine

Posaconazole

Rasagiline

Safinamide

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acepromazine

Alfentanil

Alfuzosin

Almotriptan

Alprazolam

Amineptine

Amiodarone

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Amprenavir

Anagrelide

Anileridine

Apomorphine

Aprepitant

Aripiprazole

Aripiprazole Lauroxil

Armodafinil

Arsenic Trioxide

Artemether

Asenapine

Astemizole

Azithromycin

Baclofen

Bedaquiline

Benperidol

Benzhydrocodone

Benzphetamine

Boceprevir

Bosentan

Bromazepam

Bromopride

Brompheniramine

Buprenorphine

Buserelin

Buspirone

Butabarbital

Butorphanol

Carbamazepine

Carbinoxamine

Cariprazine

Carisoprodol

Carphenazine

Ceritinib

Chloral Hydrate

Chlordiazepoxide

Chloroquine

Chlorpheniramine

Chlorpromazine

Chlorzoxazone

Ciprofloxacin

Citalopram

Clarithromycin

Clobazam

Clomipramine

Clonazepam

Clopidogrel

Clorazepate

Clozapine

Cobicistat

Cocaine

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Dabrafenib

Dantrolene

Darunavir

Dasatinib

Degarelix

Delamanid

Delavirdine

Desipramine

Deslorelin

Desmopressin

Desvenlafaxine

Deutetrabenazine

Dexamethasone

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Dezocine

Diazepam

Dibenzepin

Dichloralphenazone

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Doxylamine

Droperidol

Duloxetine

Ebastine

Eletriptan

Encorafenib

Enflurane

Enzalutamide

Eribulin

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Ethylmorphine

Famotidine

Felbamate

Fentanyl

Fingolimod

Flecainide

Flibanserin

Fluoxetine

Fluphenazine

Flurazepam

Fluspirilene

Fluvoxamine

Formoterol

Fosaprepitant

Foscarnet

Fosnetupitant

Fosphenytoin

Fospropofol

Frovatriptan

Furazolidone

Galantamine

Gatifloxacin

Gemifloxacin

Gonadorelin

Goserelin

Granisetron

Halazepam

Halofantrine

Haloperidol

Halothane

Hexobarbital

Histrelin

Hydrocodone

Hydromorphone

Hydroquinidine

Hydroxychloroquine

Hydroxytryptophan

Hydroxyzine

Ibutilide

Idelalisib

Iloperidone

Imatinib

Imipramine

Indinavir

Inotuzumab Ozogamicin

Iproniazid

Isocarboxazid

Isoflurane

Ivabradine

Ivacaftor

Ivosidenib

Ketamine

Ketazolam

Ketobemidone

Lapatinib

Leuprolide

Levofloxacin

Levomilnacipran

Levorphanol

Linezolid

Lisdexamfetamine

Lithium

Lofepramine

Lofexidine

Lomitapide

Lopinavir

Lorazepam

Lorcaserin

Loxapine

Lumacaftor

Lumefantrine

Lurasidone

Macimorelin

Meclizine

Mefloquine

Melitracen

Melperone

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Metaxalone

Methamphetamine

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methylene Blue

Metoclopramide

Metronidazole

Mibefradil

Midazolam

Mifepristone

Milnacipran

Mirtazapine

Mitotane

Mizolastine

Moclobemide

Modafinil

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Moxifloxacin

Nafarelin

Nafcillin

Nalbuphine

Naratriptan

Nefazodone

Netupitant

Nialamide

Nicomorphine

Nilotinib

Nitrazepam

Nitrous Oxide

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Olanzapine

Ondansetron

Opipramol

Opium

Opium Alkaloids

Orphenadrine

Osimertinib

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Palbociclib

Paliperidone

Palonosetron

Panobinostat

Papaveretum

Papaverine

Paregoric

Paroxetine

Pasireotide

Pazopanib

Peginterferon Alfa-2b

Pentamidine

Pentazocine

Pentobarbital

Perampanel

Perazine

Periciazine

Perphenazine

Phenelzine

Phenobarbital

Phenytoin

Pimavanserin

Pipamperone

Piperacetazine

Pipotiazine

Piritramide

Pitolisant

Prazepam

Prednisone

Primidone

Probucol

Procainamide

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propafenone

Propofol

Protriptyline

Quazepam

Quetiapine

Quinidine

Quinine

Ramelteon

Ranitidine

Ranolazine

Remifentanil

Remoxipride

Ribociclib

Rifabutin

Rifampin

Rifapentine

Risperidone

Ritonavir

Rizatriptan

Secobarbital

Selegiline

Sertindole

Sertraline

Sevoflurane

Sibutramine

Sodium Oxybate

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

St John's Wort

Sufentanil

Sulpiride

Sunitinib

Suvorexant

Tacrolimus

Tamoxifen

Tapentadol

Telaprevir

Telavancin

Telithromycin

Temazepam

Tetrabenazine

Thiethylperazine

Thiopental

Thiopropazate

Thiothixene

Tianeptine

Tilidine

Tipranavir

Tizanidine

Tolonium Chloride

Topiramate

Toremifene

Tramadol

Tranylcypromine

Trazodone

Triazolam

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Trimipramine

Triptorelin

Tryptophan

Vandetanib

Vardenafil

Vemurafenib

Venlafaxine

Verapamil

Vilanterol

Vilazodone

Vinflunine

Voriconazole

Vorinostat

Vortioxetine

Zaleplon

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abacavir

Atazanavir

Didanosine

Etravirine

Fosamprenavir

Nevirapine

Peginterferon Alfa-2a

Stavudine

Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Drug dependence, especially narcotic abuse or dependence, history of or

Gallbladder disease or

Head injuries, history of or

Heart disease (eg, cardiac hypertrophy) or

Heart rhythm problems (eg, arrhythmia, long QT syndrome), or history of or

Hypokalemia (low potassium in the blood) or

Hypomagnesemia (low magnesium in the blood) or

Increased pressure in your head or

Stomach or bowel problems or

Weakened physical condition—Use with caution. May increase risk for more serious side effects.

Hypotension (low blood pressure) or

Pancreatitis (inflammation of the pancreas) or

Seizures, history of—Use with caution. May make these conditions worse.

Kidney disease or

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Lung or breathing problems (eg, asthma), severe or

Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.

Proper Use of methadone

This section provides information on the proper use of a number of products that contain methadone. It may not be specific to Diskets Dispersible. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, chew, or dissolve it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For pain:

For patients taking Dolophine® as the first pain medicine:

Adults—At first, 2.5 milligrams (mg) every 8 to 12 hours. Your doctor may adjust your dose as needed. Do not take more than your prescribed dose in 24 hours.

Children—Use and dose must be determined by your doctor.

For patients switching from other opioids to Dolophine®:

Adults—The dose must be determined by your doctor based on the previous dose of opioid medicine. The dose is given every 8 or 12 hours. Your doctor may adjust your dose as needed. Do not take more than your prescribed dose in 24 hours.

Children—Use and dose must be determined by your doctor.

For opioid addiction:

Adults—At first, 20 to 30 milligrams (mg) taken as a single dose per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day. Do not take more than your prescribed dose in 24 hours.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you are taking this medicine for opioid addiction and miss a dose, take your next dose the following day as scheduled.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Methadone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Precautions While Using Diskets Dispersible

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for anxiety or benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may be habit-forming (causing mental or physical dependence). If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, trouble breathing, slow heartbeat, seizures, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn child. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Diskets Dispersible Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

changes in skin color

chest discomfort or pain

confusion

convulsions

cough

coughing that sometimes produces a pink frothy sputum

decreased urine output

difficult or troubled breathing

difficult, fast, noisy breathing, sometimes with wheezing

difficulty with swallowing

dilated neck veins

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

extreme fatigue

fainting

fast, slow, or irregular heartbeat

headache

hives, itching, or skin rash

increased sweating

increased thirst

irregular heartbeat

irregular, fast or slow, or shallow breathing

loss of appetite

muscle pain or cramps

nausea or vomiting

numbness or tingling in the hands, feet, or lips

pain

pale or blue lips, fingernails, or skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

sweating

swelling of the face, fingers, feet, or lower legs

tenderness

trouble sleeping

trouble urinating

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Absent, missed, or irregular menstrual periods

anxiety

blurred or loss of vision

confusion about identity, place, and time

constipation

decreased interest in sexual intercourse

disturbed color perception

double vision

false or unusual sense of well-being

halos around lights

inability to have or keep an erection

irritability

lack or loss of strength

loss in sexual ability, desire, drive, or performance

night blindness

overbright appearance of lights

redness, swelling, or soreness of the tongue

restlessness

stopping of menstrual bleeding

tunnel vision

weight changes

welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.